NCT02098213

Brief Summary

Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

4.4 years

First QC Date

March 17, 2014

Last Update Submit

January 6, 2020

Conditions

Plaque Psoriasis

Keywords

plaque psoriasisDLQIVQ DermatoPASIPASI changephototherapybalneotherapyhydrotherapyEuroquol EQ 5d scaleVisual analogic scaleSPA treatment ScalePSS

Outcome Measures

Primary Outcomes (1)

  • Dermatology Quality of Life Index (DQLI)

    proportion of patients with a score ≤ 10 at 4½ months in each arm of the study, spa treatment versus usual care.

    4 ½ months after randomisation

Secondary Outcomes (9)

  • Specific Quality Of Life

    4 1/2, 6, 9 and 12 months after randomisation

  • Global Quality Of Life

    4 1/2, 6, 9 and 12 months after randomisation

  • Clinical benefit of the psoriasis

    4 1/2, 6, 9 and 12 months after randomisation

  • pain and pruritus

    4 1/2, 6, 9 and 12 months after randomisation

  • Treatment follow up

    4 1/2, 6, 9 and 12 months after randomisation

  • +4 more secondary outcomes

Study Arms (2)

Immediate Spa treatment

ACTIVE COMPARATOR

Three week course of spa treatment soon after randomization

Other: Immediate spa treatment

Late Spa treatment

SHAM COMPARATOR

Three week course of spa treatment soon after 4,5 months visit

Other: Late Spa treatment

Interventions

Immediate spa treatmentOTHER

soon after randomization: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all participating of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)

Also known as: Spa treatment soon after randomisation
Immediate Spa treatment
Late Spa treatmentOTHER

soon after 4,5 months visit: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)

Also known as: Spa treatment after 4,5 months visit in the study
Late Spa treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both sexes, over 18 years of age, patients with plaque psoriasis for more than one year diagnosed by a dermatologist
  • Stable treatment in the last 6 months
  • DLQI score \> 10
  • patients volunteering for spa treatment within 6 weeks
  • consenting to participate to the study with informed consent form signed after appropriate information
  • Affiliation to the French social security system or equivalent

You may not qualify if:

  • Pregnancy, parturient or breast feeding
  • Psychiatric illness or social situation that would preclude study compliance
  • Refusal of consent
  • Refusal of spa treatment
  • Contra-indication to spa treatment
  • Phototherapy in the last 3 months
  • Guttate, pustular or erythrodermic psoriasis Isolated nail psoriasis
  • Spa therapy in the past year
  • Person deprived of liberty or under legal guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Station Thermale Avene

Avène, Languedoc-Rousillon, 34260, France

Location

Thermes de Molitg les bains

Molitg-les-Bains, Languedoc-Roussillon, 66500, France

Location

Thermes La Roche Posay

La Roche-Posay, Poitou-Charentes, 86270, France

Location

Les thermes de ST-GERVAIS

Le Fayet, Rhône-Alpe, 74190, France

Location

Etablissement thermal d'Uriage

Uriage-les-Bains, Rhône-Alpe, 38410, France

Location

Related Publications (20)

  • Halverstam CP, Lebwohl M. Nonstandard and off-label therapies for psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):546-53. doi: 10.1016/j.clindermatol.2007.10.023.

    PMID: 18755374BACKGROUND

  • Kazandjieva J, Grozdev I, Darlenski R, Tsankov N. Climatotherapy of psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):477-85. doi: 10.1016/j.clindermatol.2008.05.001.

    PMID: 18755366BACKGROUND

  • ALT J, NONCLERCQ E. [Treatment of psoriasis by ultraviolet and photosensitizers]. Bull Soc Fr Dermatol Syphiligr. 1953 Jul-Oct;60(4):343-5. No abstract available. Undetermined Language.

    PMID: 13115903BACKGROUND

  • Grupper C, Bourgeois-Spinasse J, Eisenmann D. [Treatment of psoriasis in 1970]. Cah Med. 1970 Sep;11:Suppl:15-20. No abstract available. French.

    PMID: 5454618BACKGROUND

  • Oddoze L, Temime P, Marchand JP, Benne M. [Combined oral meladinine and ultraviolet rays in the treatment of psoriasis. (Preliminary note)]. Bull Soc Fr Dermatol Syphiligr. 1967;74(5):609-10. No abstract available. French.

    PMID: 5587899BACKGROUND

  • SOLOMON WM, NETHERTON EW, NELSON PA, ZEITER WJ. Treatment of psoriasis with Goeckerman technic. Arch Phys Med Rehabil. 1955 Feb;36(2):74-7. No abstract available.

    PMID: 13229486BACKGROUND

  • Young E. Ultraviolet therapy of psoriasis: a critical study. Br J Dermatol. 1972 Oct;87(4):379-82. doi: 10.1111/j.1365-2133.1972.tb07426.x. No abstract available.

    PMID: 4562168BACKGROUND

  • van de Kerkhof PC. Therapeutic strategies: rotational therapy and combinations. Clin Exp Dermatol. 2001 Jun;26(4):356-61. doi: 10.1046/j.1365-2230.2001.00829.x.

    PMID: 11422189BACKGROUND

  • Weinstein GD, White GM. An approach to the treatment of moderate to severe psoriasis with rotational therapy. J Am Acad Dermatol. 1993 Mar;28(3):454-9. doi: 10.1016/0190-9622(93)70067-4.

    PMID: 8445062BACKGROUND

  • Lebwohl M. Combining the new biologic agents with our current psoriasis armamentarium. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S118-24. doi: 10.1016/s0190-9622(03)01144-7.

    PMID: 12894135BACKGROUND

  • Tabolli S, Calza A, Di Pietro C, Sampogna F, Abeni D. Quality of life of psoriasis patients before and after balneo -- or balneophototherapy. Yonsei Med J. 2009 Apr 30;50(2):215-21. doi: 10.3349/ymj.2009.50.2.215.

    PMID: 19430554BACKGROUND

  • Grob JJ, Auquier P, Martin S, Lancon C, Bonerandi JJ. Development and validation of a quality of life measurement for chronic skin disorders in french: VQ-Dermato. The ReseaudEpidemiolo gie en Dermatologie. Dermatology. 1999;199(3):213-22. doi: 10.1159/000018250.

    PMID: 10592400BACKGROUND

  • Hsu S, Papp KA, Lebwohl MG, Bagel J, Blauvelt A, Duffin KC, Crowley J, Eichenfield LF, Feldman SR, Fiorentino DF, Gelfand JM, Gottlieb AB, Jacobsen C, Kalb RE, Kavanaugh A, Korman NJ, Krueger GG, Michelon MA, Morison W, Ritchlin CT, Stein Gold L, Stone SP, Strober BE, Van Voorhees AS, Weiss SC, Wanat K, Bebo BF Jr; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. doi: 10.1001/archdermatol.2011.1410.

    PMID: 22250239BACKGROUND

  • Pathirana D, Ormerod AD, Saiag P, Smith C, Spuls PI, Nast A, Barker J, Bos JD, Burmester GR, Chimenti S, Dubertret L, Eberlein B, Erdmann R, Ferguson J, Girolomoni G, Gisondi P, Giunta A, Griffiths C, Honigsmann H, Hussain M, Jobling R, Karvonen SL, Kemeny L, Kopp I, Leonardi C, Maccarone M, Menter A, Mrowietz U, Naldi L, Nijsten T, Ortonne JP, Orzechowski HD, Rantanen T, Reich K, Reytan N, Richards H, Thio HB, van de Kerkhof P, Rzany B. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2009 Oct;23 Suppl 2:1-70. doi: 10.1111/j.1468-3083.2009.03389.x.

    PMID: 19712190BACKGROUND

  • Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.

    PMID: 18795920BACKGROUND

  • Tsai TF, Ho JC, Song M, Szapary P, Guzzo C, Shen YK, Li S, Kim KJ, Kim TY, Choi JH, Youn JI; PEARL Investigators. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci. 2011 Sep;63(3):154-63. doi: 10.1016/j.jdermsci.2011.05.005. Epub 2011 May 20.

    PMID: 21741220BACKGROUND

  • Shikiar R, Bresnahan BW, Stone SP, Thompson C, Koo J, Revicki DA. Validity and reliability of patient reported outcomes used in psoriasis: results from two randomized clinical trials. Health Qual Life Outcomes. 2003 Oct 8;1:53. doi: 10.1186/1477-7525-1-53.

    PMID: 14613569BACKGROUND

  • Shikiar R, Willian MK, Okun MM, Thompson CS, Revicki DA. The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006 Sep 27;4:71. doi: 10.1186/1477-7525-4-71.

    PMID: 17005043BACKGROUND

  • Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.

    PMID: 357213BACKGROUND

  • Beylot-Barry M, Mahe E, Rolland C, de la Breteque MA, Eychenne C, Charles J, Payen C, Machet L, Vermorel C, Foote A, Roques C, Bosson JL. Evaluation of the benefit of thermal spa therapy in plaque psoriasis: the PSOTHERMES randomized clinical trial. Int J Biometeorol. 2022 Jun;66(6):1247-1256. doi: 10.1007/s00484-022-02273-7. Epub 2022 Mar 26.

    PMID: 35347400DERIVED

Study Officials

  • Marie MB BEYLOT-BARRY, Professor

    Bordeaux University Hospital - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Taking into account the hypothesis of a proportion of patients with a DLQI≤10 (absence of repercussion or low impact of psoriasis on quality of life) of 25% at 4 months 1/2 in the arm immediate spa treatment versus 10% in the usual care group (late spa treatment), 113 patients per group is required, with an alpha 5% risk and a power of 80 %. Given the risk of potential patients lost to follow-up estimates of 15%, we plan to include 130 patients per randomisation group, so 260 patients in total. According to the protocol submitted to authorities, given the uncertainties of necessary hypothesis, a re-evaluation of the number of subjects required after the first 100 inclusions is planned. This reassessment will be carried out without intermediate analysis but in view of the results observed for the primary endpoint in mean and standard deviation (event driven).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 27, 2014

Study Start

January 1, 2015

Primary Completion

May 15, 2019

Study Completion

December 1, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations

FR(5)